Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
testing lab.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: Borfluorid-Tetrahydrofuran
Lot No. 5/93

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Young adult rabbits were used. They were singly housed in stainless wire mesh cages (no bedding) in fully air-conditioned rooms with a temperature of 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 hours dark and 12 hours light. The animals were offered a standardized rabbit laboratory diet (130 g/animal/day) as well as tap water (ca. 130 g/animal/day).
The acclimatization period was at least 1 week. Body weight determination was done shortly before application of the test substance.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: the fur was removed by clipping the dorsal of the trunk of the animal
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
3 minutes, 1 hour
Observation period:
3-min exposure: 72 hours
1-hour exposure: 24 hours
Number of animals:
3 (3-min exposure); 1 (1-h exposure)
Details on study design:
Application site: upper third of the back or flanks
Application volume: The test patches (2.5 x 2.5 cm) were moistened with 0.5 ml of the liquid test substance.
Readings were done 1 h, 24 h, 48 h and 72 h after removal of the test patches.
A check for general observations and for any dead or moribund animal(s) was made twice each working day and once on weekendes and public holidays.
Additional investigation: Because the visual assessment of the skin did not allow a statement with respect to the depth of necrotic changes, a cross incision of the trated skin has been performed after the rabbit was killed at study termination.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 3-min application
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Remarks on result:
other: 3-min application
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
other: not determined due to study termination after 24 h
Irritant / corrosive response data:
1-hour application: The average score for irritation could not be calculated because of visual necrosis and therefrom resulting study termination 24 hours after removal of the test patch.
Other effects:
The necrotic change of the skin was assessed by macroscopic pathology indicating full-thickness necrosis.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information